FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Immunology ×
3,792 results
841–864 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 14, 2002
K-ASSAY HS-CRP CONTROLS
K022486 · DCK
Kamiya Biomedical Co.
Immunology · 16d
Cleared Aug 05, 2002
ELECSYS ANTI-TG TEST SYSTEM
K020672 · JZO
Roche Diagnostics Corp.
Immunology · 157d
Cleared Jul 30, 2002
NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT
K021231 · MMW
Matritech, Inc.
Immunology · 103d
Cleared Jul 30, 2002
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
K021482 · NIY
Inova Diagnostics, Inc.
Immunology · 83d
Cleared Jul 29, 2002
FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
K013263 · LKP
Fred Hutchinson Cancer Research Center
Immunology · 301d
Cleared Jul 29, 2002
CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
K021757 · DCN
Good Biotech Corp.
Immunology · 61d
Cleared Jul 24, 2002
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K020828 · LTK
Bayer Corp.
Immunology · 132d
Cleared Jul 23, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
K021516 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 74d
Cleared Jul 19, 2002
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
K021572 · DCN
Beckman Coulter, Inc.
Immunology · 66d
Cleared Jul 16, 2002
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
K022041 · JJY
Bio-Rad Laboratories, Inc.
Immunology · 22d
Cleared Jul 16, 2002
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
K022083 · CFN
The Binding Site, Ltd.
Immunology · 20d
Cleared Jul 12, 2002
QAB2A IGM ELISA KIT HRP
K021610 · MSV
Cheshire Diagnostics , Ltd.
Immunology · 57d
Cleared Jul 12, 2002
QAB2A IGG ELISA KIT HRP
K021611 · MSV
Cheshire Diagnostics , Ltd.
Immunology · 57d
Cleared Jul 11, 2002
CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
K021882 · DCN
Good Biotech Corp.
Immunology · 34d
Cleared Jul 09, 2002
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
K021394 · DHR
Diamedix Corp.
Immunology · 68d
Cleared Jul 05, 2002
RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
K022018 · LJM
Rhigene, Inc.
Immunology · 15d
Cleared Jun 27, 2002
RDI HS CRP CALIBRATOR SET
K021607 · JIT
Reference Diagnostics, Inc.
Immunology · 42d
Cleared Jun 21, 2002
DIMENSION TPSA CALIBRATOR, MODEL #RC459
K020980 · JIT
Dade Behring, Inc.
Immunology · 87d
Cleared Jun 17, 2002
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070...
K021081 · DFZ
The Binding Site, Ltd.
Immunology · 75d
Cleared Jun 10, 2002
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
K021381 · JJY
Dade Behring, Inc.
Immunology · 40d
Cleared Jun 04, 2002
HYPERION VISIQUANT ANA TEST KIT
K013213 · DHN
Hyperion, Inc.
Immunology · 251d
Cleared Jun 03, 2002
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
K021257 · LKJ
Diagnostic Products Corp.
Immunology · 45d
Cleared May 30, 2002
IMMULITE 2000 SPECIFIC ALLERGENS
K021206 · DHB
Diagnostic Products Corp.
Immunology · 44d
Cleared May 30, 2002
IMMULITE 2000 MIXED ALLERGEN PANELS
K021208 · DHB
Diagnostic Products Corp.
Immunology · 44d